BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PRO PEN NEEDLE

    MDR report key: 10744092 · Received October 27, 2020

    Report

    Report Number
    9616656-2020-01066
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    July 22, 2020
    Report Date
    December 2, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-03. H6: INVESTIGATION SUMMARY: TWENTY OPEN 32G X 4MM PEN NEEDLE SAMPLES WITHOUT TEARDROP LABELS WERE RETURNED. AS NO TEARDROP LABELS WERE RETURNED WE CANNOT CONFIRM HOW MANY SAMPLES WERE FROM EACH LOT. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ELEVEN SAMPLES AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE REMAINING NINE SAMPLES. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TEST COULD BE CARRIED OUT. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PRO PEN NEEDLE WAS BLOCKED DURING THE INJECTION. LOT#'S 9071890 AND 9253749 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "NEEDLES "BLOCK" DURING THE INJECTION."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9071890, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-03-12, MEDICAL DEVICE LOT #: 9253749, MEDICAL DEVICE EXPIRATION DATE: 2024-09-30, DEVICE MANUFACTURE DATE: 2019-09-10. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PRO PEN NEEDLE WAS BLOCKED DURING THE INJECTION. LOT#'S 9071890 AND 9253749 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "NEEDLES "BLOCK" DURING THE INJECTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209663 BD ULTRA-FINE PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1